Recall Z-1563-2014 ยท FIP Subsystem, Water Purification
Mar Cor Purification
Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.
| Date | May 6, 2014 (initiated Apr 24, 2014) |
| Status | Terminated |
| Reason | Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106. This correction has been initiated due to a potential situation with a specific lot of the water inlet solenoid valve. The potential exists that the water inlet solenoid valve could cease to function. If this occurs, CWP will stop producing reverse osmosis water. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent on 4/24/2014 a Mar Cor Purification "Urgent Medical Device Correction" letter. The letter described the problem and the product involved in the recall. Advised consignees to examine their CWP unit to determine if it is subject to this correction. If your unit is involved in the recall inform all staff of the potential issue. Contact Scott Nicholas, Project Coordinator / Service Trainer at 1-800-633-3038 to schedule replacement of the water inlet solenoid valve. This correction is to be carried to the user level. Consignees were requested to complete and return the "CWP |
| Quantity | 197 |
| Distribution | US Nationwide Distribution - AL, AZ, AR, CA, CO, FL, GA, ID, IN, IA, KS, KY, LA, MA, MI, MN, MS, MO, MT, NH, NJ, NM, NY,NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WV, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974899 | GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H Gambro Healthcare, Sep 23, 1998 |